🇪🇺 Beyfortus in European Union

EMA authorised Beyfortus on 31 October 2022

Marketing authorisation

EMA — authorised 31 October 2022

  • Application: EMEA/H/C/005304
  • Marketing authorisation holder: Sanofi Winthrop Industrie
  • Local brand name: Beyfortus
  • Indication: Beyfortus is indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in:i.        Neonates and infants during their first RSV season.ii.        Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season (see section 5.1).Beyfortus should be used in accordance with official recommendations. Beyfortus is indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in:i.     &n
  • Pathway: PRIME
  • Status: approved

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Beyfortus in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Respiratory approved in European Union

Frequently asked questions

Is Beyfortus approved in European Union?

Yes. EMA authorised it on 31 October 2022.

Who is the marketing authorisation holder for Beyfortus in European Union?

Sanofi Winthrop Industrie holds the EU marketing authorisation.